|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
German Clinical Trials Register |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
DRKS00007651 |
|
Date of registration:
|
09/01/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The influence of the utilization time of different power toothbrushes on oral hygiene assessed over a 6-month observation period: a randomized clinical trial (RCT)
|
|
Scientific title:
|
The influence of the utilization time of different power toothbrushes on oral hygiene assessed over a 6-month observation period: a randomized clinical trial (RCT) - power toothbrush study |
|
Date of first enrolment:
|
01/07/2007 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00007651 |
|
Study type:
|
interventional |
|
Study design:
|
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: prevention
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Dirk
Ziebolz |
|
Address:
|
Robert-Koch-Str. 40
37099
Göttingen
Germany |
|
Telephone:
|
0551-3922877 |
|
Email:
|
dirk.ziebolz@med.uni-goettingen.de |
|
Affiliation:
|
Universitätsmedizin Göttingen, Poliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie |
|
|
Name:
|
Dirk
Ziebolz |
|
Address:
|
Robert-Koch-Str. 40
37099
Göttingen
Germany |
|
Telephone:
|
0551-3922877 |
|
Email:
|
dirk.ziebolz@med.uni-goettingen.de |
|
Affiliation:
|
Universitätsmedizin Göttingen, Poliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: caries-free and sufficiently conservatively and prosthetically treated dentition, minimum of 20 of their own teeth, and prevention-oriented behavior.
Exclusion criteria: diabetes mellitus, infectious diseases (hepatitis A/B/C, HIV),
renal failure,
seizure or neurological disorders,
addiction (alcohol, drugs),
pregnancy,
required antibiotic prophylaxis due to endocarditis risk or immunosuppression (e.g., due to organ transplantation or rheumatoid arthritis), or fixed orthodontic appliances.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
healthy volunteers were included
oral hygiene
|
|
Intervention(s)
|
Group 1: continuous toothbrush utilization over 6 months (non-renewal group): The participants were allocated into three subgroups according to TB used (oscillating-rotating: ProfessionalCare™ 7000, Procter&Gamble Service GmbH, Schwalbach am Taunus, Germany, sonic active: SoniCare™, Philips GmbH, Hamburg, Germany, and vibrating manual: Dr. Best Vibration®, GlaxoSmithKline, Bühl, Germany); over the 6 month observation period, only the test toothbrush, according the group, with one toothpaste was used for the whole study period with twice-daily brushing.
Group 2: renewal of toothbrush every 4 weeks over 6 months (renewal group): The participants were allocated into three subgroups according to TB used (oscillating-rotating: ProfessionalCare™ 7000, Procter&Gamble Service GmbH, Schwalbach am Taunus, Germany, sonic active: SoniCare™, Philips GmbH, Hamburg, Germany, and vibrating manual: Dr. Best Vibration®, GlaxoSmithKline, Bühl, Germany); over the 6 month observation period, only the test toothbrush, according the group, with one toothpaste was used for the whole study period with twice-daily brushing and renewal of TB every 4 weeks.
|
|
Primary Outcome(s)
|
end point: plaque accumulation (QHI), gingival inflammation (PBI), gingival trauma (GI)
time of measurement: Baseline and 2, 8, 12, 16, and 24 Wochen after Baseline, as well as finally at week 26
|
|
Source(s) of Monetary Support
|
|
Universitätsmedizin Göttingen, Poliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie
|
|
Ethics review
|
Status: Approved
Approval date: 03/05/2007
Contact:
ethik@med.uni-goettingen.de
Ethikkommission der Universitätsmedizin Göttingen
+49-551-3961261
ethik@med.uni-goettingen.de
|
|